Adverse neurological events after sodium tetradecyl sulfate foam sclerotherapy – A prospective, observational study of 8056 treatments

Background Ultrasound guided foam sclerotherapy (UGFS) is a flexible and highly utilised tool in the treatment of varicose veins (VVs), both as a primary treatment and as an adjunct to other treatments. Concern remains regarding the risk of neurological adverse events (AEs) such as migraine, visual disturbance and serious adverse events (SAEs) such as cerebrovascular accident that have been reported after UGFS treatments. Aim To determine the incidence of neurological AEs and SAEs after UGFS. Methods A prospective, multicentre, post-authorisation safety study across Europe (both private and government) was performed between January 2015–2020. Neurological adverse events after UGFS with Fibrovein® (Sodium Tetradecyl Sulfate) 1 and 3% physician generated foam. Results 8056 patients underwent treatment. There were 46 AE (including 5 SAEs), 30 (65%) SAEs were in female patients. Mean age was 55 years with mean body mass index (BMI) of 27. Univariable logistic regression demonstrate that UGFS only treatment (i.e. no adjunctive treatment), liquid-to-gas ratio, gas type and total foam volume (1% sodium tetradecyl sulfate, STS) were significantly associated with the odds of experiencing the outcome. Multivariable logistic regression model exhibits that migraine and total foam volume (1% STS) maintained statistical significance thus associated with the odds of adverse events. Conclusions This study demonstrates that UGFS with Fibrovein is safe with a very low incidence of neurological AEs and SAEs. Past history of migraine, use of physiological gas (O2/CO2) and increasing volumes of 1% foam increase the risk of AEs.

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Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures

Journal of Child Neurology ◽

10.1177/0883073819890997 ◽

2019 ◽

Vol 35 (4) ◽

pp. 265-273 ◽

Cited By ~ 4

Author(s):

Mark Mintz ◽

Jesus E. Pina-Garza ◽

Steven M. Wolf ◽

Patricia E. McGoldrick ◽

Sergiusz Józwiak ◽

...

Keyword(s):

Adverse Events ◽

Pediatric Patients ◽

Safety Data ◽

Adjunctive Treatment ◽

Eslicarbazepine Acetate ◽

Serious Adverse Events ◽

Double Blind ◽

Focal Seizures ◽

Clear Dose Response ◽

Cluster Seizures

Objective: To evaluate the safety and tolerability of adjunctive eslicarbazepine acetate (ESL) in pediatric patients (aged 4-17 years) with refractory focal seizures. Methods: Pooled safety data from patients aged 4-17 years in Study 208 (NCT01527513) and Study 305 (NCT00988156) were analyzed. Both were randomized, double-blind, placebo-controlled studies of ESL as adjunctive treatment in pediatric patients with refractory focal seizures receiving 1 or 2 antiepileptic drugs. Incidences of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), TEAEs leading to discontinuation, and TEAEs of special interest were evaluated. Results: The safety population comprised 362 patients (placebo, n = 160; ESL, n = 202). The overall incidence of TEAEs was similar between the ESL (67.8%) and placebo groups (65.6%), with no clear dose-response relationship. The most frequently reported TEAEs with ESL were headache, somnolence, vomiting, and diplopia. Overall incidences of SAEs and TEAEs leading to discontinuation were higher with ESL versus placebo (9.9% vs 5.0% and 5.9% vs 2.5%, respectively). The majority of SAEs with ESL occurred in Study 305. Two deaths were reported, 1 with ESL (0.5%) due to cluster seizures (resulting in herniation of the cerebellar tonsils) and 1 with placebo (0.6%) due to asphyxia. TEAEs related to allergic reaction, hyponatremia, hypothyroidism, cytopenia, seizure exacerbation, cognitive dysfunction, psychiatric disorders, or suicide occurred infrequently (<9%). Conclusion: Adjunctive ESL was generally well tolerated in children aged 4-17 years with focal seizures. The safety profile of ESL in children was comparable to that observed in adults.

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Foam and liquid sclerotherapy for varicose veins

Phlebology The Journal of Venous Disease ◽

10.1258/phleb.2009.09s007 ◽

2009 ◽

Vol 24 (1_suppl) ◽

pp. 62-72 ◽

Cited By ~ 46

Author(s):

P Coleridge Smith

Keyword(s):

Medical Literature ◽

Recent Literature ◽

Varicose Veins ◽

Visual Disturbance ◽

Optimum Ratio ◽

Ultrasound Guided ◽

Foam Sclerotherapy ◽

Serious Adverse Events ◽

Diverse Range ◽

Systemic Complications

Objective The objective of this study is to review the methods and outcome of ultrasound-guided foam sclerotherapy (UGFS) for the treatment of superficial venous incompetence. Method Medical literature databases including Medline were searched for recent literature concerning UGFS. Papers describing methods and outcome have been assessed and their main findings included in this summary. A detailed description of the methods used by the author has been included as an example of how successful the treatment may be achieved. Results A diverse range of practice is described in published literature in this field. Each group of authors used their own variation of the methods, described in the published literature, with good results. It is clear that foam sclerotherapy is far more effective than liquid sclerotherapy and that ultrasound imaging allows the treatment to be delivered accurately to affected veins. There is evidence that 3% policocanol foam is no more effective than 1% polidocanol foam. The optimum ratio of gas to liquid is 4:1, although a range of ratios is reported in published work. There is a wide variation in the volume used as well as the method by which it is injected. The use of carbon dioxide foam reduces the systemic complications, particularly visual disturbance, when compared with air foams. Very few serious adverse events have been reported in the literature despite the widespread use of this method. Rates of recanalization of saphenous trunks following UGFS are similar to those observed after endovenous laser and endovenous radiofrequency ablation of veins, as well as the residual incompetence after surgical treatment. Conclusions UGFS is a safe and effective method of treating varicose veins. The relative advantages or disadvantages of this treatment in the longer term are yet to be published.

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Transient adverse events positively associated with patent foramen ovale after ultrasound-guided foam sclerotherapy

Phlebology The Journal of Venous Disease ◽

10.1258/phleb.2008.008060 ◽

2009 ◽

Vol 24 (3) ◽

pp. 114-119 ◽

Cited By ~ 30

Author(s):

Pauline Raymond-Martimbeau

Keyword(s):

Adverse Events ◽

Sensitivity And Specificity ◽

Patent Foramen Ovale ◽

Varicose Veins ◽

High Sensitivity ◽

Foramen Ovale ◽

Ultrasound Guided ◽

Foam Sclerotherapy ◽

Phone Calls

Objectives To prospectively study the association between patent foramen ovale (PFO) detected by contrast transcranial Doppler (cTCD) and adverse events (AEs) reported by patients after ultrasound-guided foam sclerotherapy (UGFS) for the treatment of varicose veins. Methods All patients reporting AEs after UGFS were studied using cTCD directed at the middle cerebral artery to determine the Spencer grading score by counting high-intensity transient signals. Agitated saline was used as the contrast medium. The Spencer grading score determined the presence or absence of PFO. All patients undergoing UGFS received follow-up phone calls within 24 hours and again two weeks after the procedure. Results Of the 3259 patients who underwent UGFS, AEs were reported by seven (0.21%) patients at their first session. These included visual disturbance, migraine and chest discomfort. Five (71.4%) of these seven patients tested positive for PFO by cTCD. The two-week follow-up confirmed no permanent symptoms. Published studies show high sensitivity and specificity for cTCD when compared with contrast transesophageal echocardiography (cTEE). Conclusions The overall rate of AEs reported is consistent with published results. The presence of a PFO was detected in most patients reporting AEs after undergoing UGFS. While PFO screening with high sensitivity and specificity can be performed efficiently in the clinic setting, based on the literature, further investigation is warranted.

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P452 Oral ciclosporin is a convenient, effective and safe rescue therapy in steroid refractory Acute Severe Ulcerative Colitis: A single tertiary centre experience

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.576 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S447-S447

Author(s):

C D Jiang ◽

T Thalagala ◽

D Rosembert ◽

M Parkes ◽

J Lee ◽

...

Keyword(s):

Ulcerative Colitis ◽

Adverse Events ◽

Rescue Therapy ◽

Statistical Significance ◽

Similar Efficacy ◽

Serious Adverse Events ◽

Free Survival ◽

Severe Ulcerative Colitis ◽

Tertiary Centre ◽

Steroid Refractory

Abstract Background Parenteral ciclosporin (CsA) is an effective rescue therapy for acute severe ulcerative colitis (ASUC) and has similar efficacy to infliximab (IFX). Although CsA is cheaper and can facilitate bridging to any IBD therapy, including newer biologics, its use is limited by variable pharmacokinetics and possibility of significant systemic toxicity particularly associated with the intravenous preparation. Despite favourable pharmacokinetics and bioavailability, the use of lipid-emulsified oral CsA in steroid-refractory ASUC is undefined. Methods All patients who received oral CsA (Neoral®) rescue therapy for ASUC at Addenbrooke’s Hospital, Cambridge, UK from Nov 2014 to May 2020 were identified from electronic healthcare records. Baseline data and outcomes were extracted and compared to patients who received IFX rescue therapy. Statistical significance was assessed using non-parametric tests. Survival estimates were computed using the Kaplan-Meier method. Results A total of 37 patients received oral CsA for refractory ASUC. Median time from admission to CsA initiation was 5 days (IQR 4–6 d) and median initial dose was 8 mg/kg/d (IQR 7–8 mg/kg/d). At admission, the median CRP was 26 (IQR 14–95) and Truelove and Witt’s severity criteria met in 21/37 (57%). 70% of patients (26/37) avoided colectomy during the index admission. No parameters were demonstrated to predict need for acute colectomy. Median follow-up after hospital discharge was 3 years (IQR 2-5years). For those who avoided acute colectomy, median duration of therapy was 4 months (IQR 2.5-5months) with bridging to azathioprine (24/26, 92%), vedolizumab (1/26, 4%), or 5-ASA (1/26, 4%). Estimated colectomy-free survival in responders were 84%, 84% and 78% at 12, 24, and 60 months. No parameters were shown to predict colectomy-free survival. Comparable colectomy-free outcomes were obtained for contemporaneous IFX-treated ASUC patients in our hospital. 9 of 26 patients remained biologic-naïve and colectomy-free after a median of 3 years. Estimated colectomy and biologic-free survival were 51%, 47% and 18% at 12, 24, and 60 months. 15 patients experienced adverse events, which were all mild and self-limiting. There were 3 infective complications. No patients required drug cessation and no serious adverse events associated with parenteral CsA occurred. Conclusion In this cohort, oral CsA was a safe, well tolerated and effective rescue therapy for steroid-refractory ASUC. A proportion of patients remain biologic and colectomy-free for up to 5 years. Given the feasibility to bridge to effective maintenance therapies, including newer biologics, oral CsA should be considered as a rescue therapy in ASUC and avoids many of the side effects associated with intravenous CsA.

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Sclerotherapy and foam sclerotherapy for varicose veins

Phlebology The Journal of Venous Disease ◽

10.1258/phleb.2009.009050 ◽

2009 ◽

Vol 24 (6) ◽

pp. 260-269 ◽

Cited By ~ 55

Author(s):

P Coleridge Smith

Keyword(s):

Recent Literature ◽

Varicose Veins ◽

Visual Disturbance ◽

Optimum Ratio ◽

Foam Sclerotherapy ◽

Serious Adverse Events ◽

Systemic Complications ◽

Published Evidence ◽

Early Results ◽

Clinical Series

Objectives To review published evidence concerning treatment of varicose veins using ultrasound-guided foam sclerotherapy (UGFS) to assess the safety and efficacy of this treatment. Methods Medical literature databases including MedLine, Embase and DH-DATA were searched for recent literature concerning UGFS. Papers describing the early results and later outcome have been assessed and their main findings were included in this summary. Results Few randomized studies have been published in this field and much of the available data come from clinical series reported by individual clinicians. It is clear that foam sclerotherapy is far more effective than liquid sclerotherapy and that ultrasound imaging allows the treatment to be delivered accurately to affected veins. There is evidence that 3% polidocanol foam is no more effective than 1% polidocanol foam. The optimum ratio of gas to liquid is 4:1, although a range of ratios is reported in the published work. There is a wide variation in the volume used as well as the method by which it is injected. The use of carbon dioxide foam reduces the systemic complications, particularly visual disturbance, as compared with air foams. Very few serious adverse events have been reported in the literature despite the widespread use of this method. Rates of recanalization of saphenous trunks following UGFS are similar to those observed after endovenous laser and endovenous RF ablation of veins, as well as the residual incompetence after surgical treatment. Conclusion UGFS is a safe and effective method of treating varicose veins. The relative advantages or disadvantages of this treatment in the longer term have yet to be published.

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Complications, Indication and Tolerance of Foam Sclerotherapy in Varicose Vein Management Done in A Tertiary Care Centre in South India

International Healthcare Research Journal ◽

10.26440/ihrj/0410.01379 ◽

2021 ◽

Vol 4 (10) ◽

pp. OR7-OR14

Author(s):

Punitha Thetrarauv Oli ◽

Mahitha MC

Keyword(s):

Varicose Veins ◽

Statistical Significance ◽

Femoral Vein ◽

Tertiary Care ◽

International Standards ◽

Foam Sclerotherapy ◽

Tertiary Care Centre ◽

Validated Questionnaire ◽

Procedural Complications ◽

Recurrent Ulcers

INTRODUCTION: Foam sclerotherapy is used for treating varicose veins in our institution for patients who are not willing for surgery, debilitated patients, recurrent ulcers, cosmetic & in SFV (Sapheno Femoral Vein) <6 mm size. AIM: The aim of this study was to find and assess the rate and pattern of post–sclerotherapy complications in our institution compared with international standards. MATERIALS AND METHOD: The present study was retrospective in nature and case records of patients who underwent foam sclerotherapy [2009-2013, lower limb-Ultrasound (USG) guided and blind] in our hospital [10% Sodiumtetradecylsulfate (STS), Tessari technique] were assessed to look for indication, tolerance to the procedure and immediate outcomes. A pre-tested and pre-validated questionnaire was used and physical examination were done to assess post-procedural complications. Statistical significance was p< 0.05. RESULTS: Among 112 patients, 62.5 % were aged >50 years and 69% were males. It was observed that 22% had indication as recurrence; 43% had mild pain during procedure and 36.6% developed post-foam sclerotherapy complications. 47.6% of patients whose age were <50 years had CEAP(Clinical Etiological Anatomical Pathological) criteria C2(p=0.007). 48.8% with complications had multiple criteria(p=0.012) and 57.7% C2 had least complication (p=0.000). Cosmetic indication showed least tolerance. Use of 10% STS was found to have lesser complication rate (36%), compared to study which had 76% success with STS 3% and complication-64%. CONCLUSION: Foam sclerotherapy is less invasive and its efficacy could be improved by performing under USG guidance, selection of sclerosant, appropriate candidate (age>50 years, multiple CEAP criteria, without pre-existing co-morbidities).

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Should foam made with physiologic gases be the standard in sclerotherapy?

Phlebology The Journal of Venous Disease ◽

10.1177/0268355514560275 ◽

2014 ◽

Vol 30 (9) ◽

pp. 580-586 ◽

Cited By ~ 6

Author(s):

M Wong

Keyword(s):

Side Effects ◽

Adverse Events ◽

Visual Disturbance ◽

Foam Sclerotherapy ◽

Serious Adverse Events ◽

Randomized Controlled ◽

Increased Risk ◽

Pros And Cons ◽

Cerebral Arterioles ◽

Meta Analyses

Objectives The aim of this paper is to look at the pros and cons of using physiologic gas to produce foam for use in sclerotherapy. With the expanding use of foam sclerotherapy, there have been increased reports of transient neurologic adverse events such as visual disturbance. Although rare, increased numbers of serious adverse events such as transient ischemic attacks (TIAs) and stroke have been described. These events are seen more often in patients who have migraine with aura and those with a right-to-left shunt. Methods A literature search of the databases Ovid and Google Scholar was performed for studies looking specifically at neurologic side effects associated with sclerotherapy and use of physiologic foams. Included studies were randomized controlled trials, meta-analyses, review articles, observational studies and case studies. Results Although physiologic gases have been shown in several studies to reduce the incidence of visual disturbance, increasing evidence from recent studies suggest endothelin, rather than gas bubbles to be the cause of these side effects. The cause of stroke and TIA has not been proven and occlusion of cerebral arterioles from gas emboli should still be considered. Many authors state that only good quality foam be injected and volumes should be kept low in an attempt to prevent these rare, but potentially serious events. Foam made with physiologic gases are more biocompatible compared to air-based foam and have been found to be at least as effective in sclerotherapy as foam made with room air. Conclusion The use of physiologic gases should be considered for those at increased risk of neurologic side effects such as migraineurs with aura and those with a known PFO. Additionally, as there are few disadvantages to the use of physiologic foam, the use of CO2 or CO2/O2 foam should be considered in all patients receiving foam sclerotherapy.

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Sclerotherapy

10.2310/vasc.2120 ◽

2020 ◽

Author(s):

Melissa L Kirkwood ◽

Khalil H. Chamseddin

Keyword(s):

Varicose Veins ◽

Preoperative Evaluation ◽

Caustic Solution ◽

Hand Position ◽

Sodium Tetradecyl Sulfate ◽

Foam Sclerotherapy ◽

Left Posterior ◽

Before And After ◽

Operative Planning ◽

Planning Technique

Sclerotherapy involves the injection of a caustic solution into an abnormal vein so as to cause localized destruction of the venous intima and obliteration of the vessel. Over the past 50 years, improvements in the technology have greatly enhanced the results achievable with sclerotherapy. To ensure optimal results, it is essential to have a thorough knowledge not only of the technique but also of the indications, expected outcomes, and possible complications associated with the procedure. This review covers preoperative evaluation, operative planning, technique and complications associated with sclerotherapy. Figures show a 63-year-old woman before and after two treatments with 0.2% sodium tetradecyl sulfate, a 52-year-old woman before and after two treatments with 0.5% sodium tetradecyl sulfate, a 36-year-old woman before and after four treatments with a combination of 0.5% and 0.2% sodium tetradecyl sulfate, the standard hand position for sclerotherapy, skin necrosis on the left posterior calf of a 48-year-old woman after ultrasound-guided sclerotherapy, a 56-year-old woman before treatment and with residual hyperpigmentation after treatment with 0.2% sodium tetradecyl sulfate, and telangiectatic matting in a 43-year-old woman after treatment with 0.2% sodium tetradecyl sulfate. Tables list complications of sclerotherapy, suggested polidocanol (POL) and sodium tetradecyl sulfate (STS) concentrations for liquid and foam sclerotherapy, materials needed for sclerotherapy, and absolute and relative contraindications for sclerotherapy for varicose veins. Key Words: Varicose veins, Chronic venous insuffiency, sclerotherapy, foam sclerotherapy, reticular veins, venous disorders This review contains 7 highly rendered figures, 4 tables, and 29 references.

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Sclerotherapy

DeckerMed Surgery ◽

10.2310/surg.2120 ◽

2020 ◽

Author(s):

Melissa L Kirkwood ◽

Khalil H. Chamseddin

Keyword(s):

Varicose Veins ◽

Preoperative Evaluation ◽

Caustic Solution ◽

Hand Position ◽

Sodium Tetradecyl Sulfate ◽

Foam Sclerotherapy ◽

Left Posterior ◽

Before And After ◽

Operative Planning ◽

Planning Technique

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Real-world data of the association between quality of life using the EuroQol 5 Dimension 5 Level utility value and adverse events for outpatient cancer chemotherapy

Supportive Care in Cancer ◽

10.1007/s00520-020-05443-8 ◽

2020 ◽

Vol 28 (12) ◽

pp. 5943-5952

Author(s):

Chiemi Hirose ◽

Hironori Fujii ◽

Hirotoshi Iihara ◽

Masashi Ishihara ◽

Minako Nawa-Nishigaki ◽

...

Keyword(s):

Quality Of Life ◽

Logistic Regression ◽

Peripheral Neuropathy ◽

Adverse Events ◽

Cancer Chemotherapy ◽

Proportional Odds ◽

Utility Value ◽

Serious Adverse Events ◽

Outpatient Chemotherapy

Abstract Background Outpatient cancer chemotherapy may lead to improved quality of life (QOL) by allowing treatment to continue without impairing the social lives of patients compared with hospitalization. However, the occurrence of serious adverse events may cause a decline in QOL. We investigated the relationship between outpatient chemotherapy–induced adverse events and QOL. Methods A single-center retrospective descriptive study was conducted in patients who received outpatient chemotherapy at Gifu University Hospital (Gifu, Japan) between September 2017 and December 2018. The utility values of QOL, type and severity of adverse events, type of cancer, chemotherapy regimen, and other patient demographics were analyzed. Adverse events were graded according to the Common Terminology Criteria for Adverse Events, version 4.0. QOL was evaluated using the Japanese version of the EuroQol 5 Dimension 5 Level (EQ-5D-5L). Associations between the EQ-5D-5L utility value and serious adverse events were assessed using adjusted (age and sex) odds ratios obtained with a proportional odds logistic regression model. Results Data from 1008 patients who received 4695 chemotherapy cycles were analyzed. According to proportional odds logistic regression, the adverse events that significantly correlated with a decreased EQ-5D-5L utility value were malaise, edema of the limbs, peripheral neuropathy, pruritus, and dry skin. Based on the proportional odds logistic analysis, neither cancer type nor anticancer drugs were significantly correlated with the EQ-5D-5L utility value in patients who received chemotherapy. Pharmaceutical care for peripheral neuropathy significantly improved patients’ EQ-5D-5L utility value from 0.747 to 0.776 (P < 0.01). Conclusions Adverse events (i.e., peripheral neuropathy, malaise, and edema of the limbs) are significantly correlated with a decrease in QOL, regardless of the type of cancer or anticancer drugs used. Pharmaceutical care provided by pharmacists in collaboration with physicians may improve QOL.

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